Relexxii (methylphenidate ER [OROS]) Full Prescribing Information DailyMed Drug Information Relexxii is a tablet-shaped version of Concerta, offering the same OROS delivery system and bioequivalence. It also comes in additional dosage strengths. Forms/Strengths Tablets: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, 72 mg Dosing Age: ≥ 6 y/o Onset: ~60 min Duration: 8-12 hours Release Profile: 20% IR, 80% CR via osmotic delivery Considerations:  Must be swallowed whole; the non-absorbable shell may pass in stool. Administer once daily in the morning, with or without food. Do not chew or crush the tablet. Initial Dose: 6-12 y/o: 18 mg once daily in the morning 13+ y/o: 18 mg once daily in the morning Titration: Increase by 18 mg/day at weekly intervals Max Dose: 6-12 y/o: 54 mg/day 13+ y/o: 72 mg/day Adults: 72 mg/day Quick Facts Blocks dopamine/norepinephrine reuptake; improves focus, attention, and impulse control Extended-release formulation with a unique multi-phase release for rapid onset and sustained effect Once-daily dosing for consistent ADHD symptom management Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort Indications   ADHD (ICD-10: F90.0) Off-Label Uses  N/A How to Take Take once daily in the morning to minimize the risk of insomnia. Can be taken with or without food . Swallow the tablet whole with liquid ; do not chew, divide, or crush. Avoid taking late in the day to prevent sleep disturbances. Side Effects   Common: Decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, increased sweating. Pediatric patients: Abdominal pain Monitoring / Labs Cardiovascular : Baseline and routine monitoring of heart rate and blood pressure. Growth in Pediatrics : Regular monitoring of height and weight to detect growth suppression. Psychiatric Symptoms : Observe for mood changes, anxiety, or psychosis. Abuse Potential : Monitor for misuse or diversion. Education When to Call the Doctor: Severe mood changes, aggression, or suicidal thoughts . Chest pain, rapid heartbeat, shortness of breath ( cardiovascular concerns ). Uncontrolled movements, tics, or worsening anxiety. Numbness, coldness, or color changes in fingers or toes ( circulatory issues ). Unexplained weight loss or delayed growth in pediatric patients . Safety Tips: Monitor blood pressure and heart rate , especially in patients with cardiovascular risk. Use caution in patients with anxiety, bipolar disorder, or psychosis , as symptoms may worsen. Avoid caffeine and other stimulants , which may amplify side effects. Ensure adequate hydration and nutrition , as appetite suppression is common. Tapering may be required if discontinuing after long-term use. Parent Tips for Pediatric Patients: Encourage a nutrient-dense diet to counteract appetite suppression. Administer in the morning before school for optimal effect. Monitor school performance and behavioral changes . Observe for sleep disturbances ; adjust timing if necessary. Communicate regularly with teachers and caregivers about medication effects. Additional Information Contraindications: Hypersensitivity to methylphenidate or formulation components. Use within 14 days of MAOI therapy (risk of hypertensive crisis). Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma . History of substance use disorder , unless benefits outweigh risks. Pregnancy: Category C ; use only if benefits outweigh risks. May cause neonatal withdrawal symptoms or low birth weight . Lactation: Excreted in breast milk ; not recommended due to potential infant exposure. Drug Interactions: Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk . Acidifying agents (e.g., ascorbic acid) may reduce drug absorption. Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels. May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).